Certification Encyclopedia | Top Ten Q&A in Quality Management Systems

Question: Hello, I am a university graduate working in a newly established company. Since the company is new, there are no experienced seniors specialized in the ISO9001 quality system. My work involves some quality control aspects, so I want to learn about quality system knowledge to gradually standardize quality control in the company. Given this situation, how can I better get started and gradually change this status? (Beginner essentials)

Answer:

First, you need to achieve three points:

First, leadership attention;

Second, full participation;

Third, establish an assessment mechanism.

Then implement according to the following steps: choose a good consulting agency (not mandatory) - conduct enterprise research - organize standard learning - plan the system well - draft documents by the enterprise itself - leadership reviews one by one - release and operate - regular inspections - internal auditor training - internal audit - rectification - management review - apply for certification - continuous operation.

Question: What materials need to be prepared for our company's quality management system, environmental management system, and occupational health and safety management system audits?

Answer: The established three-standard management systems should be maintained, operated, and improved. To prepare for the annual audit by the certification body, the materials generally include:

1. Changes in the management system:

1 .  Company qualifications;

2 .  Certification scope, products, locations;

3 .  Applicable laws, regulations, and other requirements;

4 .  Policies, objectives, organizational structure.

2. Operation status:

1 .  Completion status of policies and objectives;

2 .  Process control status and product quality status;

3 .  Control status of important environmental factors and major hazards, implementation status of management plans and verification of effectiveness;

4 .  Annual training plan and training implementation status;

5 .  Annual equipment maintenance plan and implementation status, daily equipment maintenance status;

6 .  Verification and calibration status of monitoring and measuring equipment;

7 .  Procurement control and sales control status, product transportation, storage, and delivery status;

8 .  Internal and external communication of quality, environmental, and occupational health and safety information;

9 .  Product identification, environmental identification, safety identification status, including on-site preparation;

10 . Emergency preparedness and response status, including drills of emergency plans and verification of effectiveness.

3. Measurement, analysis, and improvement status:

1 . Customer satisfaction survey status;

2 . Internal audits, correction of nonconformity reports, implementation of corrective actions and verification of effectiveness;

3 .  Monitoring and measurement of processes and products, including verification of purchased products, inspection of intermediate products, and inspection of finished products;

4 .  Annual third-party testing reports, including product third-party testing reports, official testing reports of environmental factors and hazards;

5 .  Annual compliance evaluation report, environmental compliance certificate, occupational health and safety compliance certificate;

6 .  If there are newly added projects, their environmental impact assessment report, safety assessment report, and simultaneous acceptance report;

7 .  Control status of nonconforming products;

8 .  Data analysis status;

9 .  Continuous improvement, implementation status of corrective and preventive actions.

4. Document preparation:

Including "Document List", "Record List", "Laws and Regulations List", etc.

Answer: According to the "Certification Certificate Transfer Implementation Guide" formulated by the China Certification and Accreditation Association: if the original certificate is about to expire during the certification period of the original certification body, and the certified organization voluntarily transfers and can provide a statement, the transfer filing can be processed, and the new certification body can certify. However, if the certification body suspends or revokes the certificate, other certification bodies are not allowed to issue certificates to the same organization within one year from the date of suspension or revocation. If you have objections to the suspension or revocation, you can apply to the China Certification and Accreditation Association.

Answer: It is recommended that companies regularly change certification bodies to gain more improvement opportunities from different auditors' audits, and also to encourage certification bodies to have stronger service awareness for improvement and enhancement. According to the "Fair Competition Norms for Certification Bodies Related to Certification Certificates (Trial)" and the "Certification Certificate Transfer Filing Measures (Trial)" issued by CCAA (Certification and Accreditation Association), your company should first submit a filing application filled out by your company to the intended new body, with official seal and legal representative signature. The reason should be reasonable and sufficient. After the application is submitted to the association's self-regulation system and approved, you can sign a contract with the intended new body and proceed with related audit and certification work.

Question: Hello! How long is the validity period of the quality management system internal auditor qualification certificate?

Answer: Currently, there is no unified internal auditor registration system in China. The validity period is determined by the issuing institution. The National Certification and Accreditation Administration does not include "internal auditor" in certification-related training. Consulting and training institutions can issue internal auditor training certificates on their own; specific information can be inquired from the issuing institution. There is no so-called national requirement or nationally recognized qualification certificate for quality management system internal auditors. Internal auditors are qualified only when appointed by the organization itself.

Question: What should be done if the certificate expires?

Answer: Certification certificates have a specified validity period. Certificates are usually valid for three years, but some certification companies issue certificates that are valid for life. If the certificate expires, you can prepare the application materials according to the initial certification requirements and reapply for certification. The procedure is the same as when you first obtained the certificate. You can either continue with the original certification body or switch to another qualified certification body for re-certification.

Answer: Certified enterprises should prepare at least the following for supervision audits:

1 .  Changes in the quality management system, such as: administrative licenses, qualifications, types of business, organizational structure, geographic scope, key management personnel, equipment and facilities, system documents, etc.;

2 .  Information on management system performance, including: logistics professional evaluation indicators, effective control of logistics service processes, achievement of organizational policies and objectives, improvement of customer satisfaction, reduction of complaints, etc.;

3 .  Quality management system operation control mechanisms, including: internal audits, management reviews, measures taken for previous nonconformities, complaint handling, recent efforts to improve customer satisfaction, process efficiency and service quality, and enhancement of employee service capabilities;

4 .  Use of certification certificates and certification marks, indicators of effective operation of the quality system, continued process control, customer and related party satisfaction, and continuous improvement.

Note: The inability to communicate with previous employees and obtain past records for system certification work indicates a management problem within the company.

Question: May I ask if the related costs of ISO certification can be treated as intangible assets?

Answer: According to Article 67 of the Implementation Regulations of the Enterprise Income Tax Law of the People's Republic of China: amortization expenses of intangible assets calculated using the straight-line method are deductible. The amortization period of intangible assets shall not be less than 10 years. Since the validity period of the certification is less than 10 years, the certification fee cannot be recorded as an intangible asset and should be expensed as long-term deferred expenses. It is amortized using the straight-line method with no residual value. From the perspective of cost accounting, the related costs of ISO certification can be listed under prevention costs in the quality cost account.

Question: What content needs to be filled in the quality assurance system section of the bid document? Also, what should be filled in for product quality standards and product qualifications?

Answer: Since ISO9000 is well established, quality management system certification has become a qualification that many enterprises can easily obtain. It is understood that for any engineering project (including construction, system integration, security, schools, healthcare, petrochemical, transportation, etc.) and bidding activities involving specific products, the client will require bidders to fill in the "Quality Assurance System" content. If such a requirement exists, the following content can be filled in:

1 .  Has the company adopted the ISO9001 "Quality Management System - Requirements" standard and/or the GB/T50430 standard to establish its own documented quality system (usually including a quality manual, procedure documents, and various management systems and specifications)? What quality assurance measures are in place for engineering quality (people, machines, materials, methods, environment, and control)?

2 .  Is the company effectively operating the established quality management system?

3 .  Has the company applied to a nationally recognized quality management system certification body for certification of its management system (when applied, which body audited, when audited)? Has the certificate been obtained? How is the effectiveness of the quality management system maintained after certification?

4 .  Which standards, regulations, and specifications does the engineering project follow? For product bidding, which standards, regulations, and specifications must the products comply with? These must be fully identified without omissions, and obsolete standards, regulations, and specifications should not be included.

5 . For any bidding, the client will impose qualification requirements on the bidding units in the bid documents (such as certificates for architectural design, construction; security design and installation; system integration design and construction levels). Fill in whatever applies. For product bidding, products within the scope of mandatory national certification should have 3C certification; non-mandatory products should have voluntary product certification; explosion-proof equipment should have explosion-proof product certification; pressure vessels should have pressure vessel certificates; lifting machinery should have special equipment certification. Fill in whatever applies.

Question: Hello, I want to verify the authenticity of a company's quality management system certification.

Answer: You can log in to the official website of the National Certification and Accreditation Administration Committee, enter the company name and verification code on the public inquiry page to check the authenticity of its certification certificate.